Examination of witnesses (Questions 435
WEDNESDAY 15 JULY 1998
and DR BILL
435. Thank you for coming to give evidence
and assisting in our enquiry into genetic modification. Both of
your departments some months ago provided useful background information
in writing and orally on this subject. First, perhaps you would
describe briefly your areas of responsibility.
(Dr Bell) I am Jon Bell, head of the Novel Foods
Division in MAFF. My division is responsible for developing and
implementing policy on genetically-modified foods and also has
a co-ordination role in MAFF for biotechnology issues generally.
On my left is Mr Nick Tomlinson who heads the branch within my
division that deals with these issues. On my far right is Dr Linda
Smith, Head of the Biotechnology Unit at DETR, who deals with
the issue of the deliberate release of GMOs. On my immediate right
is Dr Parish, one of the senior scientists working in Dr Smith's
436. Dr Bell, to what parts of the Commission's
proposed revision of 90/220/EEC are you opposed and why?
(Dr Bell) Perhaps Dr Smith from the DETR can lead
on this matter.
(Dr Smith) DETR officials are carrying out substantive
negotiations on the directive. The United Kingdom has welcomed
the proposal from the European Commission to amend the directive
on deliberate release. The aim is to secure that the directive
retains fully the requirement to protect human health and the
environment and at the same time makes provision to allow the
technology to develop and take due account of relevant experience.
Many of the proposed changes broadly fulfil this aim. Although
the details are still to be worked out in some areas and some
amendments are needed to secure harmonised implementation across
the Community, broadly we are happy with the thrust of the directive.
However, there are some concerns. One of them
is the proposal to remove from the scope of the directive products
under development which would be covered by Community legislation
to provide for specific environmental risk assessment similar
to that in the directive. The Government are concerned that this
could have the result of environmental effects not being taken
adequately into account at the research stage because of the need
to weigh them against other considerations addressed under product
legislation. This would take the oversight of research releases
away from the competent authorities for the purposes of this directive.
These competent authorities have the relevant expertise and ability
to evaluate these environmental risk assessments. This would not
encourage public confidence in the regulatory regime and, further,
the proposal would not be helpful for those wishing to conduct
research releases because one research release might require several
approvals if this particular procedure was adopted. This could
result in far more bureaucracy and longer time than the current
maximum of 90 days before research approval was granted.
Another concern is the loss in the proposal of
the possibility for Member States' competent authorities to request
simplified procedures. Under the existing directive only one simplified
procedure has been adopted, but this has proved very important.
While it does not reduce the information and risk assessment requirements
it allows a single application to cover an entire plant breeding
programme. The Government consider that the simplified procedure
should be retained along with the facility to introduce other
simplified procedures in order that the procedures can be adjusted
if appropriate to reflect growing experience.
437. Are those
the only criticisms at the moment?
(Dr Smith) There are further points. Do you wish
me to stop here or go on?
438. I think, perhaps, I would rather like
you to continue.
(Dr Smith) There are two further concerns. The
Commission proposes to introduce two categories of research releases.
At first sight this may be thought to be equivalent to the United
Kingdom's fast track procedure for approvals for research releases
by which for certain releases our own advisory committee on releases
to the environment has identified certain things as low risk.
We are able to make decisions on applications within 30 days,
although without any reduction in the information and risk assessment
requirements. That has worked satisfactorily in the United Kingdom.
However, the approach proposed by the Commission for the two categories
is different and may be difficult to implement because the categories
are only broadly defined at present. As a consequence, we are
concerned that this may result in uneven implementation across
the Community. In addition, the procedures for the categories
for which there is considered to be sufficient experience do not
lighten the burden in terms of information requirements but only
reduce the time within which the authorities have to make a decision.
Therefore, this does not fully reflect the risk-based approach
and in future when the number of applications increases could
perhaps compromise the ability of the competent authorities to
give due consideration to less familiar releases.
The other concern is that the Commission recently
decided to seek the advice of the relevant Community level scientific
committee on all notifications to market GMOs and the proposal
for amendment of the directive would hamper this procedure. The
Government wish to ensure that any decisions made on the renewal
or otherwise of consents are based on sound science and referral
of certain notifications to a scientific committee may help to
secure this. However, the current proposal does not set out any
period within which the committee would have to assess each application;
nor does it set out the role of the committee in the approval
process. We want that to be clarified.
439. Do you think
that this may result in the whole process taking longer in future
than it does currently?
(Dr Smith) That is one of the concerns. Although
the new proposal and directive sets a clear timetable for all
the other steps in the procedure there is no timetable set for
that which could introduce lengthy delays.
440. What about the attempt to introduce
agreed principles for risk assessment? Do you think that would
be effective? Are you in favour of that?
(Dr Smith) We are very definitely in favour of
that. One of the problems with the existing directive is that
Member States have adopted different views on the risk assessment
procedure. Although there has been a competent authority working
party looking at that matter, it would be much clearer if it was
set out in the directive so that Member States could work in harmony.
441. Are you happy with the introduction
of an ethics committee?
(Dr Smith) In the recitals to the directive there
is a proposal for an ethics committee to look broadly at biotechnology
issues. We believe that that is a good idea.
442. Referring to the scientific committees
at Community level, are you happy with the method by which their
membership is determined?
(Dr Smith) We have some concerns there. It is
not completely transparent how the members of those committees
are selected. We have been trying to find out more information
443. Are you happy with the seven-year limitation
on consents for commercial releases?
(Dr Smith) We have some concerns about that for
two reasons. We do not have a problem with the idea of having
a time limit on the consent provided there is a well set out procedure
for reviewing the consent if things are satisfactory and provided
the consent continues in force until that has been resolved. There
is also a concern as to whether seven years is the appropriate
length of time. We would like to discuss that during negotiations
on the directive.
444. Do you believe that such a period should
be longer or shorter?
(Dr Smith) We have had representations both ways.
Plant breeders who have obtained marketing consent for a particular
genetically-modified crop need to breed that trait into different
varieties and perhaps seven years will not give them long enough
in order to bring those different varieties to market and make
use of them.
445. There are provisions for monitoring
in the revised directive, but it does not say much about the nature
of the monitoring. Do you think that that should be more specific?
(Dr Smith) Yes. The Government are committed to
ensuring appropriate monitoring for the introduction of genetically-modified
organisms into commercial agriculture. The existing situation
is that consents for experimental releases for marketing are given
on the basis of a risk assessment which has to demonstrate that
any risks to human health or the environment have been avoided
or minimised. The purpose of monitoring consents, particularly
after they have been granted, is to verify that the assumptions
in the risk assessment are correct. We feel that for the post-marketing
consents it should be specifically identified on a case-by-case
basis what the monitoring should be. It should be based on the
risk assessment for which the consent is granted.
Lord Wade of Chorlton
446. Are you aware of the response to these
proposals by other Member States?
(Dr Smith) The negotiations on the directive started
in the Council working group last week. There is a working group
meeting this morning at which countries will be stating their
position. Generally, there is very favourable opinion among other
Member States for the amendments to the directive, although most
countries have reservations about certain aspects and wish some
of the proposals to be clarified before they can agree with them.
Lord Willoughby de Broke
447. You said that you were in favour of
retaining the simplified procedures for research releases but
that they may be excluded under the new proposals. What sort of
support have you had for the simplified procedures route among
fellow members of the European Union?
(Dr Smith) The current simplified procedure was
an amalgamated proposal by several countries. France, Germany,
the United Kingdom and the Netherlands had proposed simplified
procedures. The one adopted was an amalgam of those proposals.
We have support among other Member States for that.
Lord Wade of Chorlton
448. It has been put to us that risk assessment
using evidence gleaned from tiny trial releases designed for safety
is a farcical process. Do you agree with that? Is there a better
way of dealing with risk assessment?
(Dr Parish) In the Government's view there are
no valid alternatives to research trials carried out in the field
to generate the necessary data for either scaling up research
trials in the environment or making applications to place a product
on the market. It is important to start with the laboratory studies
to obtain basic information, for example to detemine whether the
product may be toxic or allergenic. But that data only helps to
establish whether or not the product is hazardous. It is very
important to validate those laboratory studies in a real field
situation and find out whether those hazards are likely to be
realised and what the magnitude of the consequences may be. Therefore,
that establishes the particular risk in the field. The current
deliberate release directive sets out some important principles
in the 10th, 11th and 12th recitals with respect to the carrying
out of field trials to generate valid data to place products on
the market. They also set out the step-by-step principle whereby
one starts releasing genetically-modified organisms in very small
trials with risk management in place. For example, for oilseed
rape one may consider using isolation distances or pollen barriers.
As one generates more data from those field trials one makes an
application to scale up the size of the release. We are very much
in favour of the step-by-step principle in order to generate data
to satisfy ourselves that it is safe to scale up and once data
is available from larger releases we have data to support an application
to place the product on the market.
449. In your view how do the present risk
assessments take into account the potential secondary effects
of GM products?
(Dr Parish) It depends on how one chooses to define
the term "secondary effects". The first interpretation
is whether the genetically-modified organism has a direct effect.
For example, an insect-resistant crop may affect the target pest.
If we mean "secondary effect" to mean the effect on
those organisms that may eat or parasitise those pests then those
secondary effects are currently considered in our risk assessment.
If we mean "secondary effects" as meaning effects that
are not exerted by the GMO itself but as a result of managing
the GMO, for example changes in herbicide use or other measures
that may be necessary to grow the product in an agricultural situation,
those effects are not formally addressed in our current risk assessment
under the GMO regulations. However, it is important to bear in
mind that the use of herbicides on such crops would be governed
under other relevant legislation, for example the pesticides regulations,
which also scrutinises safety to the environment and human health
before making a decision on whether or not to give approval. We
are currently taking steps to address the wider issues in respect
of management to review our current legislation and identify whether
or not there are any gaps.
450. When you talk about the assessment
of risk are you looking for a nil risk or levels of risk which
you regard as acceptable? When does a risk become acceptable?
(Dr Parish) That is a very searching question.
First, it would be very unscientific. ACRE would not be able to
come to a judgment on the concept of zero risk. There is no such
thing as zero risk. One must accept that the growing of crops
in agricultural situations will have some side effects on wild
life, just as the result of cultivating a crop and controlling
necessarily weeds and pests. Therefore, one must look at risk
in terms of ensuring that it is minimised and address it on a
case-by-case basis for each application that is looked at.
451. There is considerable concern about
the adequacy of the steps being taken in relation to risk assessment.
The Sub-Committee has been provided with a paper by Prof Williamson
of the University of York entitled Biological Invasions
first published in 1996. This paper is concerned with modified
corn. He points out: "In corn, male sterility is a most useful
agronomic trait. . .Texas cytoplasm varieties are male sterile
because of a change in a mitochondrial gene. . . Remarkably, the
same molecular mechanism that made the plants male-sterile also
made the plants susceptible to a fungal pathogen, Bipolaris
maydis race T. About two decades after the gene, T-urf13,
came into commercial use the fungal disease devastated the corn
containing that gene, which was by that time 85 per cent of the
US corn hectareage, and made the innovation useless. The molecular
details were known, the pathogen was known, but the interaction
was not predicted and the consequences did not appear until the
new genotype was in full commercial use." That is two decades
later. It seems to me that in a situation of this sort in another
case the problem may not be a fungal infection of that species
but perhaps a secondary effect on human beings who eat that product.
Are you not concerned by evidence of this sort? How can you carry
out proper risk assessment that can cover an eventuality of that
kind? That is what causes many of us on this Sub-Committee anxiety.
(Dr Smith) In assessing any proposal whether or
not to release a genetically-modified organism the regulations
require a large body of evidence to be provided. We offer a step-by-step
approval procedure such that these trials are started in a small
way and further information is gathered before the product is
approved for marketing. Before the product is approved for marketing
it is scrutinised by the competent authorities in all the Member
States. They will make their decision based on the evidence before
them, but there is always a possibility that unpredicted effects
may arise. That is one of the reasons why monitoring of the product
once it has been approved is so important. That is why we welcome
the initiative of the Commission to take that into account. One
of the conditions of any consent that is granted is that the holders
of the consent must keep up to date with developments and inform
the competent authorities as soon as new information is available
about the particular product such that the consent can be reassessed.
If appropriate, consent can be withdrawn by the authorities. But
uncertainty and unpredicted effects are such that we have to make
the decision on the best available evidence. The monitoring and
procedures in place for checking what happens when products are
introduced on to the market are part of the consent procedure.
(Dr Bell) I very much endorse that general approach.
At the moment, we are using the best advice that we can obtain
in this country when considering these applications. That is supplemented
and amplified by the best advice that other Member States can
offer. This is not a decision that we take in isolation. It also
builds on experience that has been obtained elsewhere, including
in the United States where this technology is well advanced. But
we cannot give a one hundred per cent guarantee that every eventuality
has been covered. It is only possible to do that in the context
of the knowledge of those who are involved in it. Clearly, it
would be difficult to see how we could ever reach that position.
We shall learn from experience, and experience in other areas
indicates that products should be approved and allowed to go into
the food supply, provided they are considered safe on the basis
of current knowledge. Therefore, monitoring is a very important
back-up and reassurance for picking up any longer-term effects.
We are considering now how best that can be done.
452. To sum up what has just been said,
is it right to say that we are embarking into a potentially dangerous
(Dr Bell) I think that that is overstating the
case. Clearly, if the Government and their advisers thought that
they were taking inordinate risks in the way that these things
were being put through the system they would not be approved until
further evidence was available. This is a matter involving public
health and the Government take it very seriously as you would
expect. It will not agree to sign off a request for approval for
something to go on the market here or in the European Union that
may carry serious health risks. Every piece of scrutiny that can
possibly be carried out is carried out. This draws on knowledge
worldwide, not just in this country.
453. Dr Smith, is it a potentially dangerous
(Dr Smith) I endorse what Dr Bell has said. We
have a good understanding of plants and their biology. The advice
that we have received from our expert committee on risks to the
environment based in this country is that it would not grant a
consent unless it was satisfied that the risks had been minimised
and it had sufficient information available to it before making
that decision. If it feels that it does not have sufficient information
on a matter where it has identified a potential risk it will ask
the applicant to obtain that information before approval is granted.
454. Lord Jopling quoted the American case.
I understand that it is impossible to predict everything. But
in that particular case after 20 years 85 per cent of the US crop
was of the single variety that caused a disaster. Do you think
that there should be some arrangement to make the introduction
of new species, once consent has been agreed, more gradual, through
monitoring, and prevent a wholesale catastrophe of that sort from
(Dr Smith) I am not familiar with the paper that
has been quoted. I am not sure if the observed effect was as a
result of a genetically-modified crop or conventional breeding.
455. Professor Williamson claims it is genetically
modified: Zea mays.
(Mr Tomlinson) Given the timescale referred to
in the paper and the fact that it was being grown commercially
20 years ago, it is extremely unlikely that it is a genetically-modified
variety in the sense referred to in directive 90/220. It may well
be that a gene from another variety of maize had been incorporated
through conventional plant breeding. That points to the fact that
there is a need to ensure there is a constant turnover of plant
varieties to minimise the build up of plant diseases.
456. This is a matter that can be taken
up with Prof Williamson when he comes before the Sub-Committee
(Dr Smith) As none of us is immediately familiar
with the specific papers, perhaps we can submit a supplementary
comment after this session.
457. I should like to return to one matter
to which Dr Parish referred, namely the indirect environmental
and other effects which are not currently taken care of by existing
committees. Dr Parish said that the department was looking at
the legislative implications of taking account of that. Can you
say a little more about Government thinking in that area? We have
had various recommendations put to us either for changing the
existing remit of the environmental committee or introducing some
other overarching committee. How can account be taken of such
factors in the regulatory process?
(Dr Parish) The Government's thinking on addressing
the indirect effects is still very much in its early stages. We
have been discussing with English Nature and other bodies such
as the Royal Society for the Protection of Birds concerns about
biodiversity and the possible effect of GMOs on species if they
were introduced on a wide commercial scale. Once we have finished
our discussions with them we shall be putting proposals or options
to Ministers later this summer. That will go out for wider consultation
in the autumn. The options that have been raised, for example
expanding the remit of ACRE or having another regulatory committee
to look at overarching issues, will be considered and put to Ministers.
We are still very much in the early stages.
458. You mentioned English Nature. You will
be aware that that body has called for a moratorium for a number
of years until further research has been carried out and we know
more about the problems. This is not a wild and woolly bunch;
it is the Government's own organisation that has responsibility
for advice on nature conservation in England. Do you have a view
(Dr Smith) English Nature has submitted a paper
to this Sub-Committee. As statutory advisers to the Department
of the Environment that statement is being taken most seriously.
It is one of the inputs into the review of the way in which risks
are assessed which the Government are undertaking at the moment.
459. Therefore, you do not rule out the
possibility of a moratorium?
(Dr Smith) The evidence that has been submitted
is being considered. I should make it clear that the call by English
Nature for a moratorium is very specific. It refers to the possibility
of one particular genetically-modified crop being introduced into
commercial agriculture: GM oilseed rape. At the present it is
still awaiting marketing approval by the French competent authorities
and those responsible for putting the seed on the national list
of seed varieties in the United Kingdom or the common catalogue
in the European Union. At present this product does not have approval.